U.S. patent application number 14/004399 was filed with the patent office on 2014-07-24 for wearable personal body associated device with various physical configurations.
This patent application is currently assigned to PROTEUS DIGITAL HEALTH, INC.. The applicant listed for this patent is Yashar Behzadi, Olivier Colliou, Robert Duck, Todd Thompson. Invention is credited to Yashar Behzadi, Olivier Colliou, Robert Duck, Todd Thompson.
Application Number | 20140206976 14/004399 |
Document ID | / |
Family ID | 46831264 |
Filed Date | 2014-07-24 |
United States Patent
Application |
20140206976 |
Kind Code |
A1 |
Thompson; Todd ; et
al. |
July 24, 2014 |
Wearable Personal Body Associated Device with Various Physical
Configurations
Abstract
A body associated device comprises a housing, an adhesive layer
configured to be applied to a body of a living subject, and at
least one standoff located between the housing and the adhesive
layer. An electronic module may be located within the housing of
the body associated device. A personal communication system
comprises a body associated device including an electronic module
and further comprises a feedback portion coupled to the housing and
to the electronic module. The feedback portion is configured to
communicate information between the living subject and the body
associated device. An external local node is operative to provide
at least one of transmit communications to and receive
communications from the body associated device.
Inventors: |
Thompson; Todd; (San Jose,
CA) ; Colliou; Olivier; (Los Gatos, CA) ;
Duck; Robert; (San Francisco, CA) ; Behzadi;
Yashar; (Anaheim, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Thompson; Todd
Colliou; Olivier
Duck; Robert
Behzadi; Yashar |
San Jose
Los Gatos
San Francisco
Anaheim |
CA
CA
CA
CA |
US
US
US
US |
|
|
Assignee: |
PROTEUS DIGITAL HEALTH,
INC.
Redwood City
CA
|
Family ID: |
46831264 |
Appl. No.: |
14/004399 |
Filed: |
March 8, 2012 |
PCT Filed: |
March 8, 2012 |
PCT NO: |
PCT/US2012/028343 |
371 Date: |
January 23, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61452042 |
Mar 11, 2011 |
|
|
|
Current U.S.
Class: |
600/391 |
Current CPC
Class: |
A61B 5/0024 20130101;
A61B 5/02405 20130101; A61B 5/0488 20130101; A61B 5/01 20130101;
G06F 19/00 20130101; A61B 5/04087 20130101; A61B 5/042 20130101;
A61B 5/0022 20130101; A61B 5/145 20130101; A61B 5/6833 20130101;
A61B 5/0408 20130101; A61B 5/0809 20130101; A61B 5/1116 20130101;
A61B 2562/0219 20130101; A61B 5/0006 20130101; A61B 5/0476
20130101; A61B 2560/0412 20130101; G16H 40/67 20180101; H04B 13/005
20130101; A61B 5/021 20130101; A61B 5/1118 20130101 |
Class at
Publication: |
600/391 |
International
Class: |
A61B 5/00 20060101
A61B005/00 |
Claims
1-9. (canceled)
10. A body associated device, comprising: a housing; an adhesive
layer configured to be applied to a body of a living subject; at
least one standoff located between the housing and the adhesive
layer; and comprising at least one attachment point between the
housing and the adhesive, wherein an attachment area is defined by
the shape of the at least one standoff.
11. The body associated device of claim 10, wherein the number of
attachment points between the housing and the adhesive ranges from
at least one to 10.
12. The body associated device of claim 11, wherein the number of
attachment points between the housing and the adhesive is greater
than 10.
13-16. (canceled)
17. A body associated device, comprising: a housing; an adhesive
layer configured to be applied to a body of a living subject; at
least one standoff located between the housing and the adhesive
layer; wherein the housing is formed of a flexible material.
18. The body associated device of claim 17, wherein the housing
comprises a top portion and a bottom portion, and wherein the top
and bottom portions define at least one slot therebetween, the at
least one slot enabling the bottom portion to flex and adhere to a
contour of the body of the living subject.
19. The body associated device of claim 17, wherein the housing
comprises a curved preformed body form factor to enhance better
fitment to the body of the living subject.
20. The body associated device of claim 17, wherein the housing
defines at least one pocket formed therein to receive electrode
hydrogel therein.
21. The body associated device of claim 17, further comprising at
least one tiered pocket configured to receive electrode hydrogel
therein, wherein the tiered pocket forms an expansion slot.
22-23. (canceled)
24. A body associated device, comprising: a housing; an adhesive
layer configured to be applied to a body of a living subject; at
least one standoff located between the housing and the adhesive
layer; and an electronic module located within the housing;
comprising a transceiver electrically coupled to the electronic
module.
25. The body associated device of claim 24, comprising a switch
electrically coupled to the electronic module.
26. The body associated device of claim 24, comprising a water
ingress indicator electrically coupled to the electronic
module.
27. The body associated device of claim 24, comprising an energy
source to power an indicator electrically coupled to the electronic
module; wherein the indicator is located within the housing.
28. The body associated device of claim 27, wherein at least a
portion of the housing is formed of a translucent material to
enable energy emitted by the indicator to be discernable to the
living subject or detectable by electronic components external to
the housing.
29. The body associated device of claim 24, wherein the at least
one standoff is defined by any one of a continuous or broken ring,
square, rectangular, oval, kidney shape and a predetermined
thickness; wherein the at least one standoff defines at least one
inner aperture configured to receive an electrode hydrogel therein;
and further comprising an electrode hydrogel located in the at
least one inner aperture defined by the at least one standoff;
wherein the hydrogel is electrically coupled to the circuit
module.
30. A personal communication system, comprising: a body associated
device, comprising: a housing; an adhesive layer configured to be
applied to a body of a living subject; at least one standoff
located between the housing and the adhesive layer, wherein the at
least one standoff defines an air gap between the housing and the
adhesive layer; an electronic module located within the housing;
the body associated device to be worn by a living subject, the body
associated device further comprising a feedback portion coupled to
the housing and to the electronic module, the feedback portion
configured to communicate information between the living subject
and the body associated device; and an external local node
operative to provide at least one of transmit communications to and
receive communications from the body associated device.
31. The personal communication system of claim 30, wherein the body
associated device comprises: a physiological sensing module
operative to sense physiological information from the subject.
32. The personal communication system of claim 30, wherein the body
associated device comprises: a wireless communication module
operative to communicate at least one of communicate information
from the body associated device to the external local node or
receive information from the external local node.
33. The personal communication system of claim 30, comprising: a
remote node operative to communicate at least one of transmit
communications to and receive communications from the external
local node.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application No. 61/452,042 entitled "Wearable Personal Body
Associated Device with Various Physical Configurations" and filed
on Mar. 11, 2011, which is herein entirely incorporated by
reference.
INTRODUCTION
[0002] The present disclosure is related generally to various
configurations of a body associated device such as a patch,
wearable personal communication device, and the like. In
particular, the present disclosure is related to various physical
configurations of a wearable body associated device with structural
features that enhance a living subject's experience and comfort
when wearing the body associated device.
[0003] A broad industry with diverse product offerings is
developing around body associated devices. Such devices include
patches, personal monitors that sense physiologic parameters of a
living subject and communicate such information to body-area
network devices in communication with the personal monitor,
personal communication devices, and the like. Body associated
devices can monitor and record individual physiology, e.g.,
physical activity, heart rate, respiration, temperature, sleep,
etc., of the living subject and communicate these parameters beyond
the body of the living subject to other devices, e.g., mobile
phones, computers, internet servers, etc. A challenge for such body
associated devices is for an individual to wear or use such a
device on a continuous basis--for example, to apply an adhesive
bandage-based personal monitor to their skin for weeks, months and
potentially years and accept the possibility of its inconveniences
and limitations, such as (i) potential skin irritation, (ii) the
burden of frequent application and removal, and (iii) a feeling of
intrusiveness into the wearer's daily life.
[0004] Accordingly, there is a need for a wearable personal body
associated device with physical characteristics that offer
functional capabilities for which they are designed for as well as
structural integrity and comfort for the living subject to wear and
are easy to apply and remove from the body of the living
subject.
SUMMARY
[0005] In one aspect, a body associated device comprises a housing,
an adhesive layer configured to be applied to a body of a living
subject, and at least one standoff located between the housing and
the adhesive layer.
[0006] In another aspect, an electronic module may be located
within the housing of the body associated device.
[0007] In yet another aspect, a personal communication system
comprises a body associated device comprising an electronic module
and further comprises a feedback portion coupled to the housing and
coupled to the electronic module. The feedback portion is
configured to communicate information between the living subject
and the body associated device. An external local node is operative
to provide at least one of transmit communications to and receive
communications from the body associated device.
FIGURES
[0008] FIG. 1 is a perspective view of one aspect of a body
associated device.
[0009] FIG. 2 is a perspective view of one aspect of the body
associated device shown in FIG. 1.
[0010] FIG. 3 is a rear view of one aspect of the body associated
device shown in FIG. 1.
[0011] FIG. 4 is a front view of one aspect of the body associated
device shown in FIG. 1.
[0012] FIG. 5 is a side view of one aspect of the body associated
device shown in FIG. 1.
[0013] FIG. 6 is another side view of one aspect of the body
associated device shown in FIG.
[0014] FIG. 7 is a top view of one aspect of the body associated
device shown in FIG. 1.
[0015] FIG. 8 is a bottom view of one aspect of the body associated
device shown in FIG. 1.
[0016] FIG. 9 is a bottom view of one aspect of the body associated
device shown in FIG. 1 with an adhesive liner layer removed.
[0017] FIG. 10 is a bottom view of one aspect of the body
associated device shown in FIG. 1 with the adhesive liner and skin
base adhesive layers removed.
[0018] FIG. 11 is a side view of one aspect of the body associated
device shown in FIG. 10 with the adhesive liner and skin base
adhesive layers removed.
[0019] FIG. 12 is a perspective view of one aspect of the body
associated device shown in FIG. 11 with the adhesive liner and skin
base adhesive layers removed.
[0020] FIG. 13 is a perspective sectional view of one aspect of the
body associated device shown in FIG. 1.
[0021] FIG. 14 is a sectional side view of one aspect of the body
associated device shown in FIG. 13.
[0022] FIG. 15 is a perspective sectional view of one aspect of the
body associated device shown in FIG. 1.
[0023] FIG. 16 is a sectional side view of one aspect of the body
associated device shown in FIG. 15.
[0024] FIG. 17 is a perspective view of one aspect of the body
associated device shown in FIG. 1 with a housing cover and
functional electronic components removed.
[0025] FIG. 18 is a top view of one aspect of the body associated
device shown in FIG. 17 with the housing cover and functional
electronic components removed.
[0026] FIG. 19 is a side sectional view of one aspect of a body
associated device.
[0027] FIG. 20 is a side sectional view of one aspect of the body
associated device shown in FIG. 19 in a flexed configuration.
[0028] FIG. 21 is a side sectional view of one aspect of a body
associated device.
[0029] FIG. 22 is a side sectional view of one aspect of a form
fitting preformed body associated device.
[0030] FIG. 23 is a side sectional view of one aspect of a body
associated device.
[0031] FIG. 24 is a side sectional view of one aspect of a form
fitting preformed body associated device.
[0032] FIG. 25 is a side sectional view of one aspect of a body
associated device.
[0033] FIG. 26 is a side sectional view of one aspect of a form
fitting preformed body associated device.
[0034] FIG. 27 is a side sectional view of one aspect of a body
associated device.
[0035] FIGS. 28A-D illustrate various standoffs having different
continuous forms.
[0036] FIGS. 29A-D illustrate various standoffs having different
broken forms.
[0037] FIG. 30 illustrates one aspect of a personal communication
system in which the body associated device described herein may be
employed.
[0038] FIG. 31 is a block diagram of one aspect of a body
associated device.
[0039] FIG. 32 is a block functional diagram of one aspect of an
electronic circuit component of a body associated device.
[0040] FIG. 33 illustrates one aspect of a body associated device
configured to be placed on an external topical location of a
subject, such as a chest area.
DESCRIPTION
[0041] In one aspect, the present specification discloses multiple
configurations of a body associated device. In various aspects, the
body associated device may comprise a patch, a biocollection patch,
a patch receiver, a wearable personal communication device
("personal communicator"), among others, which may be individually
or collectively referred to herein as a "patch," without
limitation. In one aspect, a body associated device is attached to
the body of a living subject and is in communication with the
living subject. In one aspect, the body associated device also may
be in communication with a local node external to the body of the
living subject. The local node may be any form of communication
node and may comprise hardware and/or software components working
alone or in combination. In one aspect, the local node is in
communication with a remote node via a network and, accordingly,
the living subject is able to communicate with the remote node.
Information also may be communicated from the remote node and/or
the local node to the living subject via the body associated
device. In one aspect, the remote node may comprise a computer or
server configured to communicate information with the body
associated device and/or to store, manipulate, process, and manage
information received from and sent to the body associated
device.
[0042] In another aspect, the present specification discloses one
or more configurations of a body associated device that comprises,
for example, alone or in combination, a sectioned housing, a tiered
housing, a flexible housing, hydrogel pockets, base layer that
removes stiffness, multiple components assembled together, air
pockets to allow better adhesion to the body of a living subject,
tiered pockets to allow expansion of hydrogel away from the skin of
the living subject, and various body compliant or preformed body
curved form factor to enhance better fitment to the body of the
living subject.
[0043] In other aspects, the present specification discloses one or
more configurations of a body associated device that comprises
alone or in combination, for example, the features previously
described and enclosures or housing formed of various materials. In
one aspect, the enclosure may be formed of materials having
suitable flexibility to enable actuation of a button switch beneath
the housing. In other aspects, the enclosure may be formed of a
translucent material to enable energy, e.g., light, sound, etc.,
emitted by electronic components discernable to the living subject
or detectable by other electronic components external to the
housing. In other aspects, flexible electronic printed circuits are
provided for electrodes and electrical connections. For example, a
flexible electronic printed circuit can provide a significant
amount of flexibility in contrast to standard electrode
configurations. In other aspects, the body associated device
comprises a laminated-type design suitable to support manufacturing
processes, such as high volume manufacturing processes. In one
example, the laminated design is suitable for high volume web
manufacturing where a long, thin, and flexible material including
foil, metal, paper, textile, plastic, and wire are generally
processed by moving over rollers. One advantage of working with
webs is economics. Webs, being continuous, can be made at far
higher speeds and do not have the start-stop issues of discrete
sheet processing. Web processing is also found in a wide variety of
manufacturing including electronics such as circuit boards.
[0044] In other aspects, the body associated device provides a
physical housing configuration comprising a smooth shape and a low
profile that is comfortable to wear by the living subject. For
example, in various aspects, the body associated device comprises a
structural configuration that is flexible enough to enable
comfortable adhesion to the body of the living subject without
adding stress on the adhesion layer that would tend to pull the
body associated device away from the body of the living subject. In
one aspect, such flexibility and comfort may be achieved by
reducing the amount of stiffness in the structure of the body
associated device, such as the stiffness of the housing and/or
other components. Such flexibility may be achieved by patch design,
material selection, reduction in stiff sections, and reduction in
size and weight of the body associated device.
[0045] In other aspects, the body associated device provides a
waterproof fluid tight housing in accordance with IEC 60529 IPX7
specifications. Accordingly, in various aspects, the body
associated device can withstand a predefined level of submersion in
a fluid (e.g., water) without enabling the fluid to access the
electronic components of the body associated device.
[0046] In other aspects, the body associated device comprises a
skin or body adhesive layer that provides a strong adhesive
connection to the body of the living subject that is suitable for
holding the body associated device attached to the living subject
during a wear period of, for example, 1 to 3 days, 3 to 7 days, 7
to 14 days, 7 to 21 days, and so on. Such functionality may be
achieved, for example, by material selection, design and shape of
the adhesion area as well as the location of application to the
body of the living subject. In other aspects, the adhesive layer
may be selected to provide a non-irritating connection/adhesion to
the body of the living subject by selecting suitable biocompatible
materials and skin adhesives.
[0047] In other aspects, the body associated device provides
assembly features that enhance and create a flexible connection
between the body of the living subject and the body associated
device patch. In one aspect, the body associated device comprises
foam or other flexible elements, e.g., in the form of a ring, that
connect the skin adhesive to a bottom layer of the body associated
device housing (enclosure). In various aspects, such features
enable the larger skin adhesive layer to breathe and manage
absorption and release of fluid (water, perspiration) during wear.
In contrast, if the entire bottom surface area of the body
associated device was adhered to the skin of the living subject, it
would establish large areas of adhesion that would not be able to
breathe as much and would be likely to cause earlier delamination
of the body associated device patch from the skin. In one aspect,
adhesive rings without the flexible foam layer may be employed to
join the body associated device patch to the body of the living
subject. Such aspect would provide a breathable connection without
the additional thickness of the flexible foam ring material.
[0048] In other aspects, the body associated device provides
electrical connections (resistive, capacitive, inductive) to the
body of the living subject to enable the capture of electrical
signals (ECG, EKG, EMG, IEM) from the living subject. The
electrical connection may be implemented by employing a conductive
material that enables an electrical connection to the body of the
living subject while retaining fluid protection. The electrical
connection can be provided, for example, by employing Ag/AgCl
electrodes with a hydrogel interface to the skin of the living
subject. It also can be enabled by employing dry electrodes, which
provide a suitable stable connection to the body of the living
subject as described in PCT Patent Application No. PCT/US11/23017
dated Jan. 28, 2011 titled "TWO-WRIST DATA GATHERING SYSTEM" and in
PCT Patent Application No. PCT/US11/23013 dated Jan. 28, 2011
titled "DATA GATHERING SYSTEM," in which the disclosure of each is
herein incorporated by reference in its entirety.
[0049] The various aspects of a body associated device are
described hereinbelow in connection with the figures.
[0050] FIG. 1 is a perspective view of one aspect of a body
associated device 100. In various aspects the body associated
device 100 may be implemented as a patch, a biocollection patch, a
patch receiver, a wearable personal communication device ("personal
communicator"), among others, which may be individually or
collectively referred to herein as a "patch," without limitation.
The patch 100 comprises a housing 102 (e.g., enclosure), a flexible
layer 104, and an adhesive layer 106. In one aspect, the
illustrated patch 100 also comprises a flexible feedback portion
108. In one aspect, the flexible feedback portion 108 may be formed
separately (as shown) or integrally within the housing 102.
Although the flexible feedback portion 108 may serve multiple
functions, in one aspect, the flexible feedback portion 108 may be
employed in a manner to enable the living subject to communicate
with electronic modules located within the housing 102 of the patch
100. For example, in one aspect the flexible feedback module 108 is
coupled to a push button switch, such as, for example, the
pushbutton switch 140 shown in FIGS. 17, 18. With reference now
back to FIG. 1, in one aspect, the patch 100 may comprise a top
portion 110 to receive some form of indicia such as a logo,
advertising, or label. The housing 102 may be attached to the
flexible layer 104 using any suitable fastening technique
including, for example, using adhesive, glue, epoxy, silicone,
ultrasonic welding, rivets, screws, clips, snaps, etc.
[0051] In various aspects, the housing 102 may be formed in one or
more configurations. In various aspects, the housing 102 may
comprise a sectioned portion, a tiered portion, a flexible housing,
hydrogel pockets, base layer that removes stiffness, multiple
components assembled together, air pockets to allow better adhesion
to the body of a living subject, tiered pockets to allow expansion
of hydrogel away from the skin of the living subject, and various
body compliant or preformed body curved form factor to enhance
better fitment to the body of the living subject. A number of these
housing configurations will be described in more detail
hereinbelow.
[0052] In other aspects, the housing 102 or enclosure may be formed
of various materials. In one aspect, the housing 102 may be formed
of materials having suitable flexibility to enable actuation of a
flexible push button switch located beneath the housing 102. Such
configuration reduces component count and provides a suitable for
waterproof/watertight construction to support water ingress
prevention. In other aspects, the housing 102 may be formed of a
translucent material to enable light emitted by electronic
components visible to the living subject or detectable by other
electronic components external to the housing 102. Such
configuration also reduces parts count and provides a suitable
waterproof/watertight construction to support water ingress
prevention. In other aspects, flexible electronic printed circuits
are provided for electrodes and electrical connections. For
example, a flexible electronic printed circuit can provide a
significant amount of flexibility in contrast to standard electrode
configurations. In other aspects, the patch 100 comprises a
laminated-type design suitable to support high volume web
manufacturing processes.
[0053] In other aspects, the patch 100 comprises a physical housing
102 configuration comprising a smooth shape and a low profile that
is comfortable to wear by the living subject. As shown in FIG. 1,
the housing 102 comprises rounded corners and the portion comprises
a radius of curvature. Also, the aspect ratio of the housing 102 is
selected to provide a low profile. For example, in various aspects,
the housing 102 comprises a structural configuration that is
flexible enough to enable comfortable adhesion to the body of the
living subject without adding stress on the adhesion layer that
would tend to pull the body associated device away from the body of
the living subject. In one aspect, such flexibility and comfort may
be achieved by reducing the amount of stiffness in the structure of
the patch 100, such as the stiffness of the housing and/or other
components. Such flexibility may be achieved by patch design,
material selection, reduction in stiff sections, and reduction in
size and weight of the body associated device.
[0054] In other aspects, the housing 102 portion of the patch 100
provides a waterproof fluid tight housing in accordance with IEC
60529 IPX7 specifications. It will be appreciated that IEC 60529 is
a European system of test specification standards for classifying
the degrees of protection provided by the enclosures of electrical
equipment. An IPX7 designation means the patch 100 housing 102 can
withstand accidental immersion in one meter of water for up to 30
minutes. An IPX8 designation is for continuous underwater use.
Accordingly, in various aspects, the patch 100 can withstand a
predefined level of submersion in one meter of water for up to 30
minutes without enabling the fluid to access the electronic
components of the patch 100.
[0055] In various aspects, the housing 102 may be formed of a
variety of polymers. For example, the housing 102 may be formed of
plastics either thermoplastics or thermosetting polymers.
Thermoplastics are the plastics that do not undergo chemical change
in their composition when heated and can be molded multiple times.
Examples of thermoplastics include polyethylene, polystyrene,
polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE). Other
polymers include synthetic rubber, Bakelite, neoprene, nylon,
polypropylene, polyacrylonitrile, polyvinyl butyral (PVB),
silicone, acrylates, and many more. Thermosetting plastics can melt
and take shape once. After they have solidified, they stay solid.
The housing 102 may be formed of other suitable polymers including,
without limitation, natural polymeric materials such as shellac,
amber, natural rubber, and cellulose, which is the main constituent
of wood and paper. It will be appreciated that the housing 102 also
may be formed of other suitable non-polymeric materials such as
aluminum or other lightweight durable metal.
[0056] In one aspect, the adhesive layer 106 is pressure sensitive
and is configured to be applied to the skin of the living subject.
In various aspects, the adhesive layer 106 provides a strong
adhesive connection to the body of the living subject that is
suitable for holding the patch 100 attached to the living subject
during a wear period of, for example, 1 to 3 days, 3 to 7 days, 7
to 14 days, 7 to 21 days, and so on. Such functionality may be
achieved, for example, by material selection, design and shape of
the adhesion area as well as the location of application to the
body of the living subject. In other aspects, the adhesive layer
106 may be selected to provide a non-irritating connection/adhesion
to the body of the living subject by selecting suitable
biocompatible materials and skin adhesives. Examples of such
biologically compatible skin adhesive include, without limitation,
any skin adhesive that will successfully maintain the adherence of
a dermal dressing to moist (perspiring) skin on a living subject
working in hot humid environments, without producing adverse
reactions such as rashes and itching. In one aspect, the
biologically compatible skin adhesive comprises synthetic emulsions
acrylic copolymers which are odorless and pressure sensitive. Such
water-insoluble adhesives may comprise hydrophilic units to permit
strong bonding to wet human skin and still retain some water
resistance to permit durability.
[0057] The copolymer may be prepared to achieve better wet tack and
water resistance, peel adhesion and peel adhesion as a function of
rate, and may not contain any residual monomer, which is a
potential source of skin irritation. In addition, the adhesion
layer 106 comprises rounded edges, or other suitable designs
befitting the curvature of other parts of the body which further
reduce peeling discomfort from the skin as compared to sharp
edges.
[0058] FIG. 2 is a perspective view of one aspect of the body
associated device shown in FIG. 1. As shown in FIG. 2, the patch
100 further comprises a liner 112 to protect the adhesive layer 106
before the patch 100 is applied to the body of the living subject.
In use, the liner 112 is peed off the adhesive layer 106 before the
patch 100 is applied to the body of the living subject. In the
aspect of the patch 100 illustrated in FIG. 2, the patch 100
further comprises a first outer standoff 114a, an inner standoff
114b, and a second outer standoff 114c. In one aspect, the
standoffs 114a-c are ring shaped, e.g., a circular band or
continuous outer portion defining an inner aperture or space
therein, and have a predetermined thickness (see e.g., standoffs
114a-c in FIG. 12). In other aspects, in addition to the circular
ring shape of the standoffs 114a-c, the standoffs may be formed in
any suitable shape such as square, rectangle, oval, kidney, where
each of the shapes includes a continuous solid outer portion that
defines an inner aperture or space as shown in FIGS. 29A-D. In
still other aspects, the standoffs may have a broken shape. For
example, the broken standoff has a broken outer portion with an
open portion in the form of a "C," as shown in FIGS. 29A-C, or an
"E," as shown in FIG. 29D. Although not shown, in one aspect, the
circular ring shaped standoffs 114a-c can be formed in a broken "C"
like shape.
[0059] With reference now back to FIG. 2, accordingly, each of the
standoffs 114a-c define a continuous outer portion defining a
corresponding inner space or aperture inside the ring. The
standoffs 114a-c may be attached to the flexible layer 104 using
any suitable fastening techniques including, for example, using
adhesive, glue, epoxy, silicone, ultrasonic welding, rivets,
screws, clips, snaps, etc. In one aspect, the standoffs 114a-c may
be formed of a foam material that includes adhesive on one side or
on both sides of the foam material. In one aspect, the standoffs
114a-c have a thickness ranging from about 0.1 mm to about 3 mm.
The liner 112 may be attached to the standoffs 114a-c using any
suitable fastening technique including, for example, adhesive,
glue, epoxy, silicone, ultrasonic welding, etc.
[0060] In other aspects, the patch 100 provides assembly features
that enhance and create a flexible connection between the body of
the living subject and the patch 100. In one aspect, the flexible
layer 104 of the patch 100 comprises foam or other flexible
elements, e.g., in the form of rings, that connect the skin
adhesive to a bottom layer of the body associated device housing
(enclosure). In various aspects, the standoffs 114a-c are formed in
ring shape from a foam or other flexible material. In various
aspects, the standoffs 114a-c enable the larger skin adhesive layer
106 to breathe and manage absorption and release of fluid (water,
perspiration) during wear by providing air gaps 116 between the
flexible layer 104 and the adhesive layer 106. The flexible layer
104 alone has a tendency to cause condensation on the skin of the
living subject. The standoffs 114a-c provide reduced contact area
with the skin and also provide some additional flexibility. The
standoffs 114a-c are able to stretch and give because the movement
of the standoffs 114a-c is not confined to the area of the flexible
layer 104 and thus the patch 100 is more stretchable with the skin.
In contrast, if the entire bottom surface area of the patch 100 was
adhered to the skin of the living subject, it would establish large
areas of adhesion that would not be able to breathe as much and
would be likely to cause earlier delamination of the patch 100 from
the skin. Permeable materials provide a moisture vapor transition
rate (MVTR) and adhere better to the skin. In one aspect, the
adhesive layer 106 may be formed as adhesive rings without the foam
flexible layer 104. The adhesive layer 106 may be employed to join
the patch 100 to the body of the living subject. Such aspect would
provide a breathable connection without the additional thickness of
the flexible foam ring material of the standoffs 114a-c. In one
aspect, the flexible layer 104 is interposed between the standoffs
114a-c and the housing 102. In various aspects, the attachment
points between the patch 100 and the skin of the living subject may
be determined by the shape of the standoffs 114a-c. For example, in
various aspects, the number of attachments points can be anywhere
from 1 to 10 or many more than 10.
[0061] FIG. 3 is a rear view of the patch 100. FIG. 4 is a front
view of the patch. FIGS. 5 and 6 are side views of the patch 100.
The aspects of the patch 100 illustrated in FIGS. 1-6 show the
standoffs 114a-c and the air gaps 116. As shown, an air gap 116 is
defined between the first outer standoff 114a and the inner
standoff 114b and another air gap 116 is defined between the inner
standoff 114b and the second outer standoff 114c.
[0062] FIG. 7 is a top view of the patch 100 and FIG. 8 is a bottom
view of the patch 100 with the liner 112 still in place. As shown,
in FIG. 8, in one aspect the liner 112 comprises a liner seam 118
to enable easy removal of the liner 112 from the adhesive layer 106
(FIGS. 1-7).
[0063] FIG. 9 is a bottom view of one aspect of the patch 100 with
the adhesive liner 112 layer removed. As shown, the liner 112 layer
having been removed, the adhesive layer is shown 106. Three
apertures are now revealed. A first inner aperture 120a opens into
the inner space defined by the first outer standoff 114a (FIGS.
2-4, 6). A second inner aperture 120b opens into the inner space
defined by the inner standoff 114b (FIGS. 2-4). A third inner
aperture 120c opens into the inner spaced defined by the second
outer standoff 114c (FIGS. 2-4, 5).
[0064] FIG. 10 is a bottom view of one aspect of the patch 100 with
the adhesive liner 112 and skin base adhesive layer 106 removed.
FIG. 11 is a side view of one aspect of the patch 100 shown in FIG.
10 with the adhesive liner 112 and skin base adhesive layer 106
removed. FIG. 12 is a perspective view of one aspect of the patch
100 shown in FIG. 11 with the adhesive liner 112 and skin base
adhesive layer 106 removed. With reference now to FIGS. 10-12, with
the liner 112 and adhesive layer 106 removed, the structure of the
outer standoffs 114a-c can be seen. As shown, the inner apertures
120a-c defined by corresponding standoffs 114a-c are used to hold
the hydrogel and electrically couple the electrodes to the skin of
the living subject. A data label 122 is provided to display any
suitable type of information.
[0065] With reference now to FIGS. 9-12, as will be defined in more
detail below, in various aspects, the patch 100 provides electrical
connections (resistive, capacitive, inductive) to the body of the
living subject to enable the capture of electrical signals (ECG,
EKG, EMG, IEM), conductive signals, irradiative signals, etc., from
the living subject. The electrical connection may be implemented by
employing a conductive material that enables an electrical
connection to the body of the living subject while retaining fluid
protection. The electrical connection can be provided, for example,
by employing Ag/AgCl electrodes with a hydrogel interface to the
skin of the living subject. It also can be enabled by employing dry
electrodes, which provide a suitable stable connection to the body
of the living subject. Accordingly, prior to adhering the patch 100
to the skin of the living subject, the inner apertures 120a-c
defined by the standoffs 114a-c are filled with a hydrogel
conductive fluid, which is used to electrically couple the body of
the living subject to electrodes located within the patch 100. A
hydrogel (also called aquagel) is a network of polymer chains that
are hydrophilic and is commonly used in medical electrodes. Such
medical electrode hydrogels are composed of cross-linked polymers
such as polyethylene oxide,
poly(2-acrylamido-2-methyl-1-propanesulfonic acid (polyAMPS), and
polyvinylpyrrolidone, for example. The hydrogel can be placed into
the inner apertures 120a-c either at the time of manufacture, prior
to the application of the liner 112 to the adhesive layer 106 or
can be placed in the inner apertures 120a-c by the living subject
after removing the liner 112 from the adhesive layer 106 just
before applying the patch 100 to the skin.
[0066] FIG. 13 is a perspective sectional view of one aspect of the
patch 100 shown in FIG. 1. FIG. 14 is a sectional side view of one
aspect of the patch 100 shown in FIG. 13. FIG. 15 is a perspective
sectional view of one aspect of the patch 100 shown in FIG. 1. FIG.
16 is a sectional side view of one aspect of the patch 100 shown in
FIG. 15. With reference now to FIGS. 13-16, the patch 100 comprises
an electronic module located within the housing 102. Also in the
aspect of the patch 100 shown in FIGS. 13-16, the patch 100
comprises electrode hydrogel 124 located in the space defined by
the standoffs 114a-c. Furthermore, the patch 100 comprises a
battery 126 and a printed circuit board 128. In one aspect, the
printed circuit board 128 is a flexible printed circuit design for
electrodes and connections. The thin flexible printed circuit board
128 substrate material provides suitable flexibility in contrast to
conventional electrode designs. The battery powers the electronic
module and the circuit board 128 contains the electronic components
of the electronic module. An isolation film 130 electrically
isolates the printed circuit board 128 from an electrostatic
discharge (ESD) shield 132. The ESD shield 132 protects the
electronic circuit components located on the printed circuit board
128 from electrostatic discharge and/or electromagnetic
interference. Pin sockets 134 electrically connect a pushbutton
switch to a header.
[0067] FIG. 17 is a perspective view of one aspect of the patch 100
with the housing cover 102 and functional electronic components
removed. FIG. 18 is a top view of the patch 100 shown in FIG. 17
with the housing cover 102 and functional electronic components
removed. With the housing 102 and functional electronic components
removed, it can be seen that the patch 100 includes a conductive
element such as, for example, a conductive electrode. In one
aspect, the conductive element is flexible and forms a flexible
electrode circuit. Although it may form part of the same circuit,
the flexible electrode circuit is referenced as three portions of
the conductive flexible electrode circuits 136a, 136b, 136c, which
correspond to the inner apertures 120a-c and the standoffs 114a-c.
The conductive flexible electrode circuits 136a-c are located above
the corresponding standoffs 114a-c, located below the foam flexible
layer 104. In addition, the patch 100 comprises a water ingress
indicator 138 to detect water or moisture penetration into the
housing 102 (not shown in FIGS. 17, 18). A pushbutton switch 140 is
provided to receive input commands for the living subject. The pin
sockets 134 are electrically coupled to the pushbutton switch 140
and to a header 114 socket. An antenna 142 is provided for
communication between the patch 100 and the local node and/or the
remote node. In one aspect, the electronic module comprises a
transceiver coupled to the antenna 142. The antenna 142 and
transceiver enable wireless communications between the electronic
module and external local/remote nodes and/or receive information
from the local/external nodes. An indicator, e.g., a light source
146 such as a light emitting diode (LED) is provided to indicate
status and control information associated with the patch 10 and/or
the living subject.
[0068] In various aspects, the patch 100 provides electrical
connections (resistive, capacitive, inductive) to the body of the
living subject to enable the capture of electrical signals (ECG,
EKG, EMG, IEM) from the living subject. The electrical connection
may be implemented by employing a conductive material such as the
electrode hydrogel 124 (FIGS. 13-16) and flexible electrode
circuits 136a-c that enables an electrical connection to the body
of the living subject while retaining fluid protection. In one
aspect, the electrical connection can be provided, for example, by
employing Ag/AgCl flexible electrode circuits 136a-c with a
hydrogel 124 interface to the skin of the living subject. It also
can be enabled by employing dry electrodes, which provide a
suitable stable connection to the body of the living subject.
[0069] FIG. 19 is a side sectional view of one aspect of a body
associated device 200. In various aspects the body associated
device 200 may be implemented as a patch, a biocollection patch, a
patch receiver, a wearable personal communication device ("personal
communicator"), among others, which may be individually or
collectively referred to herein as a "patch," without limitation.
The patch 200 comprises a sectioned/tiered housing 202 for
flexibility, a base layer 210, and pockets 204 defined by the
housing 202. The pockets 204 are configured to receive electrode
hydrogel therein. The housing 202 comprises a top portion 212 and a
flexible bottom portion 214. The top portion 212 and the flexible
bottom portion 214 define at least one slot to remove stiffness and
enable the housing 202 to flex. In the illustrated housing 202,
slots 208a, 208b defined by the top and bottom portions 212, 214 of
the housing 202 remove housing stiffness when the housing is
flexed. An adhesive layer 206 is provided to adhere the patch 200
to the body of the living subject.
[0070] FIG. 20 is a side sectional view of one aspect of the patch
200 shown in FIG. 19 in a flexed configuration. As shown, the top
portion 214 of the housing 202 remains substantially in the same
configuration whether or not the housing 202 is flexed. The
flexible portion 214 flexes and conforms to the contours of the
body of the living subject. The slots 208a, b provide the necessary
flexibility to remove the stiffness of the housing 202.
[0071] FIG. 21 is a side sectional view of one aspect of a body
associated device 300. In various aspects the body associated
device 300 may be implemented as a patch, a biocollection patch, a
patch receiver, a wearable personal communication device ("personal
communicator"), among others, which may be individually or
collectively referred to herein as a "patch," without limitation.
The patch 300 comprises a housing 302, a base layer 304, and
pockets 308 defined by the housing 302. The pockets 308 are
configured to receive electrode hydrogel therein. An adhesive layer
310 is provided to adhere the patch 300 to the body of the living
subject. The housing 302 also includes an airgap 306 to allow for
better adhesion of the adhesive layer 310 to the body of the living
subject. The airgap 306 may be formed as a pattern in the lower
foam/flexible layer of the housing 302 to reduce adhesive contact
to the base layer 310 to allow water vapor permeation through the
base layer 304.
[0072] FIG. 22 is a side sectional view of one aspect of a form
fitting preformed body associated device 320. In various aspects
the body associated device 320 may be implemented as a patch, a
biocollection patch, a patch receiver, a wearable personal
communication device ("personal communicator"), among others, which
may be individually or collectively referred to herein as a
"patch," without limitation. The patch 320 comprises a preformed
housing 322, a base layer 324, and pockets 328 defined by the
housing 322. The preformed housing 322 comprises a preformed body
form factor with a curvature to conform to the contours of the body
of the living subject to enhance better fitment to the body of the
living subject. The pockets 328 are configured to receive electrode
hydrogel therein. An adhesive layer 330 is provided to adhere the
patch 320 to the body of the living subject. The preformed housing
322 also includes an airgap 326 to allow for better adhesion of the
adhesive layer 330 to the body of the living subject. The airgap
326 may be formed as a pattern in the lower foam/flexible layer of
the preformed housing 322 to reduce adhesive contact to the base
layer 330 to allow water vapor permeation through the base layer
324.
[0073] FIG. 23 is a side sectional view of one aspect of a body
associated device 400. In various aspects the body associated
device 400 may be implemented as a patch, a biocollection patch, a
patch receiver, a wearable personal communication device ("personal
communicator"), among others, which may be individually or
collectively referred to herein as a "patch," without limitation.
The patch 400 comprises a housing 402, a base layer 404, and
pockets 408 defined by the housing 402. The pockets 408 are
configured to receive electrode hydrogel therein. An adhesive layer
406 is provided to adhere the patch 400 to the body of the living
subject.
[0074] FIG. 24 is a side sectional view of one aspect of a form
fitting preformed body associated device 420. In various aspects
the body associated device 420 may be implemented as a patch, a
biocollection patch, a patch receiver, a wearable personal
communication device ("personal communicator"), among others, which
may be individually or collectively referred to herein as a
"patch," without limitation. The patch 420 comprises a preformed
housing 422, a base layer 424, and pockets 428 defined by the
housing 422. The preformed housing 422 comprises a preformed body
form factor with a curvature to conform to the contours of the body
of the living subject to enhance better fitment to the body of the
living subject. The pockets 428 are configured to receive electrode
hydrogel therein. An adhesive layer 426 is provided to adhere the
patch 420 to the body of the living subject.
[0075] FIG. 25 is a side sectional view of one aspect of a body
associated device 500. In various aspects the body associated
device 500 may be implemented as a patch, a biocollection patch, a
patch receiver, a wearable personal communication device ("personal
communicator"), among others, which may be individually or
collectively referred to herein as a "patch," without limitation.
The patch 500 comprises a housing 502, a base layer 504, and
pockets 508 defined by the housing 502. The pockets 508 are
configured to receive electrode hydrogel therein. The pockets 508
form expansion slots 510 to form a tiered hydrogel pocket. The
expansion slots 510 provide additional volume that allows the
hydrogel to expand towards the patch 500 and away from the body of
the living subject. An adhesive layer 506 is provided to adhere the
patch 500 to the body of the living subject. The tiered pocket 508
improves mechanical adhesion to the skin of the living subject.
[0076] FIG. 26 is a side sectional view of one aspect of a form
fitting preformed body associated device 520. In various aspects
the body associated device 520 may be implemented as a patch, a
biocollection patch, a patch receiver, a wearable personal
communication device ("personal communicator"), among others, which
may be individually or collectively referred to herein as a
"patch," without limitation. The patch 520 comprises a preformed
housing 522, a base layer 524, and tiered pockets 528 defined by
the housing 520. The preformed housing 522 comprises a preformed
body form factor with a curvature to conform to the contours of the
body of the living subject to enhance better fitment to the body of
the living subject. The tiered pockets 528 are configured to
receive electrode hydrogel therein. The tiered pockets 528 form
expansion slots 530 to form the tiered hydrogel pocket. As
discussed above, the hydrogel is the interface between the metal
flexible electrode circuits 136a-c (FIGS. 17-18). As the hydrogel
expands, the patch has a tendency to be pushed away from the skin
of the living subject and reduce electrical contact with the skin.
Accordingly, the expansion slots 530 provide additional volume that
allows the hydrogel to expand towards the patch 520 and away from
the body of the living subject. This has a tendency to reduce the
pull-away of the patch from the skin as the hydrogel expands. An
adhesive layer 526 is provided to adhere the patch 520 to the body
of the living subject. The tiered pocket 528 improves mechanical
adhesion to the skin of the living subject.
[0077] FIG. 27 is a side sectional view of one aspect of a body
associated device 540. In various aspects the body associated
device 540 may be implemented as a patch, a biocollection patch, a
patch receiver, a wearable personal communication device ("personal
communicator"), among others, which may be individually or
collectively referred to herein as a "patch," without limitation.
The patch 540 comprises a housing 542, standoffs 544a and 544b,
(544a-b), and a base layer 550, where the base layer 550 is the
adhesive layer that adheres to the skin of the living subject. In
various aspects, the standoffs 544a-b comprise a flexible inner
layer 546 and one or two adhesive outer layers 548a and/or 548b. In
one aspect, the flexible inner layer 546 is formed from foam. The
standoffs 544a-b are interposed between the patch housing 542 and
the base layer 550. The standoffs 544a-b are attached to the
housing by a first adhesive layer 548a and, in one aspect, are
attached to the base layer 550 by a second adhesive layer 548b. The
housing 542 and the base layer 550 define an airgap 552. Hydrogel
544 is located in the space defined by the standoffs 544a-b to form
a hydrogel interface to the skin of the living subject. In various
aspects, the number of attachments points can be anywhere from 1 to
10 or many more than 10. In various aspects, the standoffs 544a-b
may be formed in the shape of a continuous circular ring as shown
in FIG. 12, or a broken ring. Additionally, the standoffs 544a-b
may be formed in any of the shapes described hereinbelow with
reference to FIGS. 28A-D and 29A-D. As previously discussed, the
attachment points between the patch 540 and the skin of the living
subject may be determined by the shape of the standoffs 544, for
example, as shown in FIGS. 12, 28A-D, and 29A-D. 5.
[0078] FIGS. 28A-D illustrate various standoffs having different
continuous forms. Accordingly, in such aspects, in addition to the
circular ring shape of the standoffs 114a-c shown in FIG. 12, the
standoffs may be formed in any suitable shape such as a square
shaped standoff 570, a rectangle shaped standoff 572, an oval
shaped standoff 574, a kidney shaped standoff 576, where each of
the shapes includes a continuous solid outer portion that defines
an inner aperture or space. An electrode hydrogel may be located in
the inner aperture 571, 573, 575, 577 defined by the corresponding
standoffs 570, 572, 574, 576.
[0079] FIGS. 28A-D illustrate various standoffs having different
continuous forms. Accordingly, in such aspects, in addition to the
circular ring shape of the standoffs 114a-c shown in FIG. 12, the
standoffs may be formed in any suitable shape such as a square
shaped standoff 570, a rectangle shaped standoff 572, an oval
shaped standoff 574, a kidney shaped standoff 576, where each of
the shapes includes a continuous solid outer portion that defines
an inner aperture or space. An electrode hydrogel may be located in
the inner aperture 571, 573, 575, 577 defined by the corresponding
standoffs 570, 572, 574, 576.
[0080] FIGS. 29A-D illustrate various standoffs having different
broken forms. As shown in FIGS. 29A-D, for example, the broken
standoff has a broken outer portion with an open portion in the
form of a "C" for a broken square shaped standoff 580, a broken
rectangle shaped standoff 582, and a broken oval shaped standoff
584, and in the form of an "E" for a broken kidney shaped standoff
586 shape. Although not shown, in one aspect, the circular ring
shaped standoffs 114a-c (FIG. 12) can be formed in a broken "C"
shape. An electrode hydrogel may be located in the inner aperture
581, 583, 585, 587 defined by the corresponding standoffs 580, 582,
584, 586.
[0081] FIG. 30 illustrates one aspect of a personal communication
system 600 in which the body associated device described herein may
be employed. As illustrated in FIG. 30, a body associated device
604 is positioned on a living subject 602. The body associated
device 604 may be configured as any of the body associated devices
100, 200, 300, 320, 400, 420, 500, 520, 540 described above in
connection with FIGS. 1-27 with any of the standoff shapes
described with reference to FIGS. 12, 28A-D, 29A-D. The living
subject 602 may be a human or a non-human being. In various
aspects, the body associated device 604 may be realized in many
forms and configurations as described above in connection with
FIGS. 1-27. In addition, the body associated device 604 may be
formed as sensor-enabled patches, watches, and jewelry, bandages
with an adhesive portion, wristbands, earrings, bracelets, rings,
pendants, clothing, undergarments, hats, caps, scarves, pins,
accessories, belts, shoes, eyeglasses, contact lenses,
hearing-aides, subcutaneous implants, and other devices that are
wearable, implantable, or semi-implantable on or in the living
subject 602 without limitation. The body associated device 604 is
configured to communicate with the living subject 602 and an
external local node 606. The external local node 606 is configured
to communicate with a remote node 610 via a network 608. In one
aspect, the body associated device 604 is configured to communicate
with the remote node 610 directly. It will be appreciated that in
the context of the present disclosure, communication is intended to
encompass communications to and from the personal communicator 604
and the external local node 606. Likewise, communication is
intended to encompass communications to and from the personal
communicator 604 and the remote node 610 as well as communications
to and from the external local node 606 and the remote node
610.
[0082] The body associated device 604 may comprise any number of
distinct physiological parameter or biomarker collecting and/or
sensing capabilities. The number of distinct parameters or
biomarker collecting and/or sensing capabilities may vary e.g., one
or more, two or more, three or more, four or more, five or more,
ten or more, and so on. In certain configurations, the personal
communicator 604 comprises one or more active components that are
able to dynamically monitor and record individual physiological
parameters and/or biomarkers associated with the living subject
602. Such components include, without limitation, sensors,
electronic recording devices, processors, memory, communication
components. In one aspect, the personal communicator 604 may
include an on-board battery to supply electrical power to the
active components. The physiological parameter or biomarker sensing
abilities may include sensing cardio-data, including heart rate,
electrocardiogram (ECG), and the like, respiration rate,
temperature, pressure, chemical composition of fluid, e.g., analyte
in blood, fluid state, blood flow rate, physical activity, sleep,
accelerometer motion data, without limitation, for example.
[0083] In one aspect, the body associated device 604 provides
specific information about the state of health of the subject 602.
In another aspect, some of this information may be derived from
sensors embedded in the body associated device 604. The subject 602
may obtain the body associated device 604 with a prescription, for
example, and then wear the body associated device 604 for a
prescribed period, e.g., hours, days, weeks, months, years.
[0084] In one aspect, the body associated device 604 includes, is
configured to (a) monitor and record individual physiology, e.g.,
physical activity, heart rate, respiration, temperature, sleep,
etc., of the living subject 602 and (b) communicate these
parameters beyond the body of the living subject 102 to other
devices, e.g., mobile phones, computers, internet servers, etc., in
order to (c) enable support and collaboration for fitness,
wellbeing, disease management, sport, entertainment, gaming, and
other applications. A challenge for such body associated device 604
is creating a compelling rationale for the individual 602 to wear
or use the personal communicator 604 on a continuous basis--for
example, to apply an adhesive bandage-based body associated device
604, as described above in connection with FIGS. 1-26, to their
skin for weeks, months and potentially years and accept the
possibility of its inconveniences and limitations, such as (i)
potential skin irritation, (ii) the burden of frequent application
and removal, and (iii) a feeling of intrusiveness into the wearer's
daily life.
[0085] In one aspect, the body associated device 604, for example a
sensor patch that adheres to the skin of an individual such as the
living subject 602, communicates with its wearer by sending and
receiving tactile or other signals. The default settings may be
modified such that the body associated device 604 discreetly
vibrates or pulses in a specific manner or pattern, e.g., time or
space based, to remind the subject 602 of important events or to
communicate important personalized messages to the wearer. The
default settings also may be modified such that the subject 602 can
transmit and record meaningful inputs and messages to the body
associated device 604 by communicating a simple language of finger
taps, jiggles, scratches or other physical inputs initiated by the
subject 602. In one aspect, the living subject 602 can communicate
with the body associated device 604 through the pushbutton switch
108 (FIG. 1), which activates the switch 140 (FIG. 17). Through the
body associated device 604 communications architecture, e.g., a
Bluetooth or other communication links, to other devices beyond the
body, the composite set of sensed physiology, tactile inputs, and
outputs can be transmitted to other individuals, groups,
caregivers, and related products, e.g., online games, of the
subject's 602 choosing via the external local node 606, network
608, and/or the remote node 610. It will be appreciated that the
term "communication architecture" is intended to cover any suitable
communication architecture including, for example, body associated
device 602 "patch" controls communications, other control
communication device or devices, or any suitable permutation of a
suitable communication control set. The features of the body
associated device 604 are based on a sustained behavior change
mechanism and it increases the value and potential of body
associated device 604 and the likelihood that consumers will seek
out, use, and benefit from such body associated device 604.
[0086] In-body communications include any communication of data or
information via the body of the living subject 602, i.e.,
communication via or associated with inter-body aspects, intra-body
aspects, and a combination of the same. For example, inter-body
aspects include communications associated with devices designed to
attach to a body surface. Intra-body aspects include communications
associated with data generated from within the body, e.g., by the
body itself or by a device implanted, ingested, or otherwise
locatable in, or partially in, the body. For example, intra-body
communications are disclosed in the PCT Patent Application No.
PCT/US09/68128 dated Dec. 15, 2009, BODY-ASSOCIATED RECEIVER AND
METHOD, the entire content of which is hereby incorporated by
reference.
[0087] Communications include and/or may be associated with
software, hardware, circuitry, various devices, and combinations
thereof.
[0088] The devices include devices associated with physiologic data
generation, transmission, reception, communication. The devices
further include various implantable, ingestible, insertable, and/or
attachable devices associated with the human body or other living
organisms. As shown in FIG. 30, the body associated device 604 may
be in communication with an IEM 612 and/or an implantable pulse
generator 614 (IPG), e.g., pacer, etc., implanted near the heart
region. The devices still further include multimedia devices such
as telephones, stereos, audio players, PDAs, handheld devices, and
multimedia players.
[0089] The system for incorporating physiologic data enables
exchange, transmission, receipt, manipulation, management, storage,
and other activities and events related to physiologic data. Such
activities and events may be contained within the system for
incorporating physiologic data, partially integrated with the
system for incorporating physiologic data, or associated with
externalities, e.g., activities, systems, components, and the like
which are external to the system for incorporating physiologic
data.
[0090] The physiologic data environment includes any source of
information or data, including remote computer systems, local
computer devices. The information or data may comprise physiologic
data in whole or in part, e.g., aggregated or generated with other
types of data. The physiologic data may be pure or refined, e.g.,
physiologic data from which inferences are drawn.
[0091] As shown in FIG. 30, the body associated device 604,
regardless of form factor or implementation is in communication
with an external local node 606. In one aspect, the personal
communicator 104 includes the capability of communicating, e.g.,
receiving, transmitting, generating, and recording data directly or
indirectly from the living subject 602. Although the data may
include physiologic data, it is not limited as such. Any data of a
physiologic nature may be associated with the living subject 602.
The physiologic data may include, for example, heart rate, heart
rate variability, respiration rate, body temperature, temperature
of local environment, three-axis measurement of activity and torso
angle, as well as other physiologic data, metrics, and indicators
associated with one or more individuals. The physiologic data may
be communicated at various times or time intervals to the external
local node 606. For example, the communication may be real-time,
i.e., in close temporal proximity to a time in which the
physiologic data were generated, measured, ascertained, or on an
historical basis, i.e., in far temporal proximity to a time in
which the physiologic data was generated, measured, ascertained. In
various aspects, the physiologic data may be associated with a
variety of devices, e.g., cardiac device.
[0092] In one aspect, the external local node 606 may be configured
as a communication hub and may include any hardware device,
software, and/or communications component(s), as well as systems,
subsystems, and combinations of the same which generally function
to communicate physiologic and non-physiologic data between the
body associated device 604 and the external local node 606.
Communication of the data includes receiving, storing,
manipulating, displaying, processing, and/or transmitting the data
to the remote node 610 via the network 608.
[0093] In various aspects, the external local node 606 also
functions to communicate, e.g., receive and transmit,
non-physiologic data. Example of non-physiologic data include
gaming rules and data generated by a separate cardiac-related
device such as an implanted pacemaker and communicated to the hub
directly or indirectly, e.g., via the body associated device
604.
[0094] Broad categories of external local nodes 606 include, for
example, base stations, personal communication devices, handheld
devices, and mobile telephones. In various aspects, the external
local node 606 may be implemented as a handheld portable device,
computer, mobile telephone, sometimes referred to as a smartphone,
tablet personal computer (PC), kiosk, desktop computer, or laptop
computer, or any combination thereof. Examples of smartphones
include, for example, Palm.RTM. products such as Palm.RTM.
Treo.RTM. smartphones, Blackberry.RTM. smart phones, Apple.RTM.
iPhone.RTM. device, and the like. Although some aspects of the
external local node 606 may be described with a mobile or fixed
computing device implemented as a smart phone, personal digital
assistant, laptop, desktop computer by way of example, it may be
appreciated that the various aspects are not limited in this
context. For example, a mobile computing device may comprise, or be
implemented as, any type of wireless device, mobile station, or
portable computing device with a self-contained power source, e.g.,
battery, such as the laptop computer, ultra-laptop computer,
personal digital assistant (PDA), cellular telephone, combination
cellular telephone/PDA, mobile unit, subscriber station, user
terminal, portable computer, handheld computer, palmtop computer,
wearable computer, media player, pager, messaging device, data
communication device, and so forth. A fixed computing device, for
example, may be implemented as a desk top computer, workstation,
client/server computer, and so forth.
[0095] The external local node 606 comprises personal communication
devices including, for example, devices having communication and
computer functionality and typically intended for individual use,
e.g., mobile computers, sometimes referred to as "handheld
devices." Base stations comprise any device or appliance capable of
receiving data such as physiologic data. Examples include
computers, such as desktop computers and laptop computers, and
intelligent devices/appliances. Intelligent devices/appliances
include consumer and home devices and appliances that are capable
of receipt of data such as physiologic data. Intelligent
devices/appliances may also perform other data-related functions,
e.g., transmit, display, store, and/or process data. Examples of
intelligent devices/appliances include refrigerators, weight
scales, toilets, televisions, door frame activity monitors, bedside
monitors, bed scales. Such devices and appliances may include
additional functionality such as sensing or monitoring various
physiologic data, e.g., weight, heart rate. Mobile telephones
include telephonic communication devices associated with various
mobile technologies, e.g., cellular networks.
[0096] In various aspects, the external local node 606 may provide
voice and/or data communications functionality in accordance with
different types of cellular radiotelephone systems. Examples of
cellular radiotelephone systems may include Code Division Multiple
Access (CDMA) systems, Global System for Mobile Communications
(GSM) systems, North American Digital Cellular (NADC) systems, Time
Division Multiple Access (TDMA) systems, Extended-TDMA (E-TDMA)
systems, Narrowband Advanced Mobile Phone Service (NAMPS) systems,
3G systems such as Wide-band CDMA (WCDMA), CDMA-2000, Universal
Mobile Telephone System (UMTS) systems, WiMAX (Worldwide
Interoperability for Microwave Access, LTE (Long Term Evolution)
and so forth.
[0097] In various embodiments, the external local node 606 may be
configured to provide voice and/or data communications
functionality in accordance with different types of wireless
network systems or protocols. Examples of suitable wireless network
systems offering data communication services may include the
Institute of Electrical and Electronics Engineers (IEEE) 802.xx
series of protocols, such as the IEEE 802.1a/b/g/n series of
standard protocols and variants (also referred to as "WiFi"), the
IEEE 802.16 series of standard protocols and variants (also
referred to as "WiMAX"), the IEEE 802.20 series of standard
protocols and variants, and so forth. A mobile computing device may
also utilize different types of shorter range wireless systems,
such as a Bluetooth system operating in accordance with the
Bluetooth Special Interest Group (SIG) series of protocols,
including Bluetooth Specification versions v1.0, v1.1, v1.2, v1.0,
v2.0 with Enhanced Data Rate (EDR), as well as one or more
Bluetooth Profiles, and so forth. Other examples may include
systems using infrared techniques or near-field communication
techniques and protocols, such as electromagnetic induction (EMI)
techniques.
[0098] In one aspect, the external local node 606, for example, the
hub, includes a software application associated with a mobile
telephone of a patient. The application and mobile telephone
function to receive physiologic data from a receiver, which, in
turn, receives the physiologic data directly from an individual or
indirectly, e.g., via a device. Examples of devices include cardiac
devices and ingestible devices. The hub stores, manipulates, and/or
forwards the data, alone or in combination with other data, via the
network 608 to a remote node 610.
[0099] In various aspects, the external local node 606 (hub)
receives, generates, communicates, and/or transmits, physiologic
data, alone or in combination with other data, i.e.,
non-physiologic data from various sources. Communication from the
external local node 606 includes any transmission means or
carriers, and combinations thereof, including wireless, wired, RF,
conductive, etc. as is known in the art or as may become available
in the future.
[0100] In various aspects, the handheld device includes software,
e.g., a software agent/application, associated with the physiologic
data. In various aspects of the handheld device, the software is
preconfigured, i.e., configurable by the manufacturer/retailer;
configurable by the consumer, i.e., downloadable from a website; or
a combination of the same.
[0101] The base station includes systems, subsystems, devices,
and/or components that receive, transmit, and/or relay the
physiologic data. In various aspects, the base station communicably
interoperates with a receiver such as the body associated device
604 and a communications network 608 such as the Internet. Examples
of base stations are computers, e.g., servers, personal computers,
desktop computers, laptop computers, intelligent
devices/appliances, etc., as heretofore discussed.
[0102] In various aspects, the base station may be embodied as an
integrated unit or as distributed components, e.g., a desktop
computer and a mobile telephone in communication with one another
and in communication with a patch receiver and the Internet.
[0103] In various aspects, the base station includes the
functionality to wirelessly receive and/or wirelessly transmit
data, e.g., physiologic data received from and transmitted to the
body associated device 604 and the Internet.
[0104] Further, in various aspects, the base station may
incorporate and/or be associated with, e.g., communicate with,
various devices. Such devices may generate, receive, and/or
communicate data, e.g., physiologic data. The devices include, for
example, "intelligent" devices such as gaming devices, e.g.,
electronic slot machines, handheld electronic games, electronic
components associated with games and recreational activities.
[0105] The mobile telephone includes, for example, devices such as
a short-range, portable electronic device used for mobile voice or
data communication over a network of specialized cell site base
stations. The mobile telephone is sometimes known as or referred to
as "mobile," "wireless," "cellular phone," "cell phone," or "hand
phone (HP)."
[0106] In addition to the standard voice function of a telephone,
various aspects of mobile telephones may support many additional
services and accessories such as short message service (SMS) for
text messaging, email, packet switching for access to the Internet,
java gaming, wireless, e.g., short range data/voice communications,
infrared, camera with video recorder, and multimedia messaging
system (MMS) for sending and receiving photos and video. Some
aspects of mobile telephones connect to a cellular network of base
stations (cell sites), which is, in turn, interconnected to the
public switched telephone network (PSTN) or satellite
communications in the case of satellite phones. Various aspects of
mobile telephones can connect to the Internet, at least a portion
of which can be navigated using the mobile telephones.
[0107] In various aspects, the mobile telephone includes software,
e.g., a software agent/application, associated with the physiologic
data. One example is an auto refill application related to or
integrated with an auto refill system to facilitate automated
prescription refill functions. In various aspects of the mobile
telephone, the software is preconfigured, i.e., configurable by the
manufacturer/retailer; configurable by the consumer, i.e.,
downloadable from a website; or a combination of the same.
[0108] Further, various aspects of the hub include combinations of
devices. One such combination is the body associated device 604 in
communication with the handheld device or the mobile telephone.
Thus, for example, the body associated device 604 wirelessly
transmits physiologic data to the mobile telephone having a
receiver and a software agent available thereon. The receiver of
the mobile telephone receives the physiologic data. A software
agent, e.g., an application, processes the physiologic data and
displays various information related to the physiologic data via,
for example, a customized graphical user interface (GUI). In
various aspects, the software agent generates displays with a
predetermined "look and feel," i.e., recognizable to a user as
belonging to a predetermined group of software programs, GUIs,
source devices, communities, gaming software, etc.
[0109] More particularly, the personal communication system 600
includes any environment having therein, or associated with, data
or communication of physiologic data for a gaming or recreational
purpose. Communication includes any method, act, or vehicle of
communication, and/or combinations thereof. For example,
communication methods include manual, wired, and wireless. Wireless
technologies include radio signals, such as x-rays, ultraviolet
light, the visible spectrum, infrared, microwaves, and radio waves,
etc. Wireless services include voice and messaging, handheld and
other Internet-enabled devices, data networking.
[0110] Vehicles of communication include the network 608. In
various aspects, the network 608 comprises local area networks
(LAN) as well as wide area networks (WAN) including without
limitation Internet, wired channels, wireless channels,
communication devices including telephones, computers, wire, radio,
optical or other electromagnetic channels, and combinations
thereof, including other devices and/or components capable
of/associated with communicating data. For example, the
communication environments include in-body communications, various
devices, various modes of communications such as wireless
communications, wired communications, and combinations of the
same.
[0111] Wireless communication modes include any mode of
communication between points that utilizes, at least in part,
wireless technology including various protocols and combinations of
protocols associated with wireless transmission, data, and devices.
The points include, for example, wireless devices such as wireless
headsets, audio and multimedia devices and equipment, such as audio
players and multimedia players, telephones, including mobile
telephones and cordless telephones, and computers and
computer-related devices and components, such as printers.
[0112] Wired communication modes include any mode of communication
between points that utilizes wired technology including various
protocols and combinations of protocols associated with wired
transmission, data, and devices. The points include, for example,
devices such as audio and multimedia devices and equipment, such as
audio players and multimedia players, telephones, including mobile
telephones and cordless telephones, and computers and
computer-related devices and components, such as printers.
[0113] In one aspect, the remote node 610 comprises social network
systems, commercial systems, healthcare systems, pharmacy systems,
university systems, financial transaction systems, web communities,
physician systems, family caregiver systems, regulatory agency
systems, wholesaler/retailer systems as described in U.S. patent
application Ser. No. 12/522,249 titled "INGESTIBLE EVENT MARKER
DATA SYSTEM," the disclosure of which is herein incorporated by
reference in its entirety. In other aspects, the remote node 110
comprises state games, behavioral reflective games, psychological
response games, synchronization games, actual progress games, and
recreational games as described in PCT Patent Application No.
PCT/US09/60713 dated Oct. 14, 2009 titled "METHOD AND SYSTEM FOR
INCORPORATING PHYSIOLOGIC DATA IN A GAMING ENVIRONMENT" and
published as WO 2010/045385, the disclosure of which is herein
incorporated by reference in its entirety.
[0114] In various aspects, the personal communication system 600
provides health monitoring, assessment, and sensing in a closed
loop. Furthermore, the personal communication system 600 provides a
framework for caregivers to communicate with patients and implement
wellness and disease management programs. Using the body associated
device 604 enables such communication to be conducted in a discreet
manner. Servers at the remote node 610 may be configured as
desired, e.g., to provide for subject directed permissions. For
example, the servers may be configured to allow a family caregiver
to participate in the subject's therapeutic regimen, e.g., via an
interface (such as a web interface) that allows the family
caregiver to monitor alerts and trends generated by the server, and
provide support back to the subject 602. The servers also may be
configured to provide responses directly to the subject, e.g., in
the form of subject alerts, subject incentives, which are relayed
to the subject via the communication device. The servers also may
interact with a health care professional, e.g., RN, physician,
which can use data processing algorithms to obtain measures of
health and compliance of the subject, e.g., wellness index
summaries, alerts, cross-patient benchmarks, and provide informed
clinical communication and support back to the subject 602.
[0115] FIG. 31 is a block diagram of one aspect of a body
associated device 604. The body associated device 604 may comprise
features, in any suitable configuration and combination. In one
aspect, the body associated device 604 comprises a power unit 702,
an operation unit 704 that includes an electrode 704A, an operation
or processing unit 706, and a memory unit 708. These and other
electronic components are provided on the printed circuit board 128
(FIGS. 13-16). The body associated device 604 may include a power
management module 710 that controls the power consumption. The body
associated device 604 is configured to communicate with other
near-by devices using one or more transmitters/receivers
("transceiver") module 712. As used herein, the term "transceiver"
may be used in a very general sense to include a transmitter, a
receiver, or a combination of both, without limitation. For
example, the transceiver module 712 may be used for one-way or
two-way communications with the external local node 106 and/or the
remote node 610 (FIG. 30). Furthermore, the body associated device
604 may include various features such as an accelerometer 714 to
detect the orientation of the body associated device 604. In
instances where the subject 602 is laying down or in a horizontal
position, the body associated device 604 is capable of detecting
that position and the duration of time that the subject 602 remains
in that position. In addition to detecting the orientation of the
body associated device 604, in various aspects, the accelerometer
714 may be employed to detect other physical aspects of the body
associated device 604 such as static or dynamic acceleration
forces, proper acceleration, position, vibrations, and the
like.
[0116] Additionally, the body associated device 604 may further
include a personal monitoring portion comprising one or more
sensors 716 to detect one or more distinct physiological
parameters. By physiological parameter sensing ability is meant a
capability of sensing a physiological parameter or biomarker, such
as, but not limited to heart rate, respiration rate, temperature,
pressure, chemical composition of fluid, e.g., analyte detection in
blood, fluid state, blood flow rate, accelerometer motion data,
IEGM (intra cardiac electrogram) data.
[0117] Accordingly, the body associated device 604 may include
physiological parameter measuring tools that allows it to determine
if the subject is simply laying down or if the subject has suffered
some medical condition that has caused them to end-up in that
position. For example, the subject may have had a heart attack and
the body associated device 604 can detect that condition and in
conjunction with information from the accelerometer 714, the body
associated device 604 is able to determine that the subject has a
potentially serious medical condition. Another example includes the
instance where the subject suffers from an epileptic seizure. The
accelerometer 714 provides information to the body associated
device 604 and the information from the accelerometer 714 combined
with the measured physiological parameters allows the body
associated device 604 to determine that a medical condition is
taking place or has taken place that will require immediate
attention.
[0118] In accordance with the teaching of the present disclosure,
the signal receiver aspects of the body associated device 604 may
be configured to receive a conductive communication. The conductive
communication may be associated with any physiologic part of the
body or from a device that conductively transmits through a body
using ionic emission through controlled release of mass from solid
into a conducting solution or fluid. The communication may be
produced by an ionic emission module or an IEM or a
smart-parenteral delivery system. Ingestible event markers of
interest include those described in PCT Application Serial No.
PCT/US2006/016370 published as WO/2006/116718; PCT Application
Serial No. PCT/US2007/082563 published as WO/2008/052136; PCT
Application Serial No. PCT/US2007/024225 published as
WO/2008/063626; PCT Application Serial No. PCT/US2007/022257
published as WO/2008/066617; PCT Application Serial No.
PCT/US2008/052845 published as WO/2008/095183; PCT Application
Serial No. PCT/US2008/053999 published as WO/2008/101107; PCT
Application Serial No. PCT/US2008/056296 published as
WO/2008/112577; PCT Application Serial No. PCT/US2008/056299
published as WO/2008/112578; and PCT Application Serial No.
PCT/US2008/077753 published as WO 2009/042812; the disclosures of
which applications are herein incorporated by reference. Smart
parenteral delivery systems are described in PCT Application Serial
No. PCT/US2007/015547 published as WO 2008/008281; each of the
foregoing disclosures is herein incorporated by reference in its
entirety.
[0119] As the body associated device 604 of these aspects is
configured to receive data encoded in current flow through a
conductive fluid, the receiver and the device that emits the
communication, e.g., a current signature, (such as an ingestible
event marker 612 (IEM), FIG. 30) use the living body with which
they are associated as a communication medium. To employ the body
as a communication medium for the signal, the body fluids act as
the conducting fluid and the body of the subject is used as a
conduction medium for communication. As such, the communication
that is transferred between devices, e.g., transferred from an
ionic emission device, an RFID device, and/or other signal-emitting
devices, to a receiver, e.g., the body associated device 604,
travels through the body of the subject 602 (FIG. 30). The
conductive communication of interest may be provided through and
received from the skin and other body tissues of the body of the
subject 602 in the form of electrical alternating current (a.c.)
signals that are conducted through the body tissues. As a result,
such signal receivers do not require any additional cable or hard
wire connection between the device generating the communication and
the device receiving the communication.
[0120] The body associated device 604 may include a transbody
conductive communication module configured to receive a conductive
communication. The transbody conductive communication module is a
functional module that is configured to receive a conductive
communication, such as a communication emitted by the IEM 612 (FIG.
30). Where desired, the transbody conductive communication module
may be implemented by a high power functional block, such as
described above. In some instances, the transbody conductive
communication module is configured to receive an encoded
communication, by which is meant that the communication has been
modulated in some manner, e.g., using a protocol such as binary
phase shift keying (BPSK), frequency shift keying (FSK), amplitude
shift keying (ASK), etc. In such instances, the body associated
device 604 transbody conductive communication module is configured
to decode a received encoded communication emitted by an IEM. The
body associated device 604 may be configured to decode the encoded
communication in a low signal to noise ratio (SNR) environment,
e.g., where there may be substantial noise in addition to the
information of interest, e.g., an environment having an SNR of 7.7
dB or less. The personal communicator 104 may be further configured
to decode the encoded signal with substantially no error. In
certain aspects, the body associated device 604 has a high coding
gain, e.g., a coding gain ranging from 6 dB to 12 dB, such as a
coding gain ranging from 8 dB to 10 dB, including a coding gain of
9 dB. The body associated device 604 in accordance with various
aspects can decode encoded communications with substantially no
error, e.g., with 10% error or less.
[0121] In one aspect, the body associated device 604 comprises a
feedback module 718. The feedback module 718 may be implemented
with software, hardware, circuitry, various devices, and
combinations thereof. The function of the feedback module 718 is to
provide communication with the living subject 602 (FIG. 30) in a
discreet, tactful, circumspect manner. Accordingly, in various
aspects the feedback module 718 may be implemented to communicate
with the subject 602 using techniques that employ visual, audio,
vibratory/tactile, olfactory, and taste. Such techniques are
non-detectable by other living subjects such as humans, for
example. In one aspect, the feedback module 718 enables close,
intimate, and non-verbal communication between the subject 602 and
the body associated device 604. With the feedback module 718, the
subject 602 can develop a unique language/vocabulary for
communicating with the body associated device 604.
[0122] In one aspect, the feedback module 718 may employ visual
communication techniques using light sources to enable
communication between the subject 602 (FIG. 30) and the body
associated device 604. In various aspects, light from light
emitting diode (LED) sources, for example, may be optically
channeled to the eye of the subject 602 through optical waveguides,
fiber optics, reflection, refraction, total internal reflection, or
other optical techniques for manipulating a beam of light or pulses
of light to maintain discreet communication between the subject 602
and the body associated device 604. In other aspects, such discreet
optical communication may be implemented by way of implanted LEDs
into the structure of eyeglasses, contact lenses, or other wearable
devices, in such as manner as to be detectable only by the subject
602. In other aspects, mirrors or lens arrangements may be
configured to transmit discreet light pulses such that they are
visible only by the subject 602. In other aspects, liquid crystal
displays (LCD) may be integrated into contact lenses or eyeglasses
to provide a discreet form of visual communication between the
subject 602 and the body associated device 604. In other aspects,
infrared (IR) techniques may be employed for discreet communication
purposes.
[0123] In another aspect, the feedback module 718 may employ audio
communication techniques to enable communication between the
subject 602 (FIG. 30) and the body associated device 604. In one
aspect, the subject 602 may wear a small speaker in the form of an
ear piece, for example, such that the communication remains private
between the subject 602 and the body associated device 604. In
other aspects, the subject 602 may wear a form or hearing aid tuned
to a particular frequency such that only the subject 602 is able to
discern such audio communications. In either of the above described
aspects, the audio communication may be transmitted by wire or
wireless communication techniques. The audio communication may be
implemented in the form of text-to-speech or in the form of audible
"beeps" of varying pitch to represent a perceived fundamental
frequency of a sound to enable the subject 602 to develop a
customized dictionary. Other auditory attributes of musical tones
along with duration, loudness, timbre, and sound source location
may be employed to develop the dictionary. It will be appreciated
that pitch may be compared in terms of "higher" and "lower" in the
sense that allows the construction of melodies. Pitch may be
quantified as a frequency in cycles per second (Hz). Furthermore,
other psychoacoustical attributes of sound may be employed to carry
out communications discreetly between the subject 602 and the body
associated device 604. In other aspects, small microphones may be
employed to detect speech and convert it into an electrical
signal.
[0124] In another aspect, the feedback module 718 may employ
vibratory/tactile communication techniques to enable communication
between the subject 602 (FIG. 30) and the body associated device
604. In one aspect, the body associated device 604 may employ a
piezoelectric element or eccentric wheel (or weights) to generate
vibrations that are detectable only by the subject 602. Thus, in
one aspect, the subject 602 may tap the body associated device 604
to communicate information therewith. Piezoelectric sensors may be
used to receive taps from the subject 602 and convert the taps into
electrical impulse that can be used to communicate between the
subject 602 and the body associated device 604. Piezoelectric films
such as piezoelectric fluoropolymer (PVDF) film or KYNAR.RTM./PVDF
piezoelectric film and other such films may be employed as, or part
of, pyroelectric sensors, accelerometers, touch-sensitive sensors,
contact microphones, pickups, or drum triggers among other
devices.
[0125] In other aspects, microelectromechanical systems (MEMS)
(also written as micro-electro-mechanical, Micro ElectroMechanical
or microelectronic and microelectromechanical systems), which
employ technology of very small mechanical devices driven by
electricity may be employed to generate tactile impulses that are
perceptible only by the subject 602 (FIG. 30). MEMS devices may be
formed on very small scales and thus components between 1 to 100
micrometres in size (i.e., 0.001 to 0.1 mm) may be realized. MEMS
devices generally range in size from 20 micrometers (20 millionths
of a meter) to a millimeter and consist of a central unit that
processes data, the microprocessor and several components that
interact with the outside such as microsensors. MEMS may be
fabricated using modified semiconductor device fabrication
technologies, normally used to make electronics. These include
molding and plating, wet etching (KOH, TMAH) and dry etching (RIE
and DRIE), electro discharge machining (EDM), and other
technologies capable of manufacturing small devices. An early
example of a MEMS device is the resonistor--an electromechanical
monolithic resonator.
[0126] Other aspects of tactile communication techniques include
nerve or muscle stimulation techniques employing electrical
impulses. For example, electrical current may be employed to
stimulate muscle tissue. Electro-stimulation uses voltage in the
range of about 0 to about 40 V and current in the range of about 0
to about 80 mA. Such low electrical energy levels are not harmful
to the subject 602 and may be calibrated to optimize comfort versus
sensitivity. For example, such voltages and currents are typical in
transcutaneous electrical nerve stimulation (TENS), which currently
is one of the most commonly used forms of electroanalgesia. In one
aspect, trains of stimuli can be delivered with variable current
strengths, pulse rates, and pulse widths as adjusted by the living
subject 602. A preferred waveform is biphasic, to avoid the
electrolytic and iontophoretic effects of a unidirectional current
where typical stimulus parameters are amplitude, pulse width
(duration), and pulse rate (frequency). In one aspect, the
amplitude current may be set by the living subject 602 at a
comfortable, low intensity level, just above threshold, pulse width
may be set to anywhere in the range of about 10 to about 1000
microseconds, and the pulse rate may be set to anywhere in the
range of about 80 to about 100 impulses per second (Hz); about 0.5
to about 10 Hz when the stimulus intensity is set high, for
example. In one aspect, electrodes are placed in contact with the
surface of the skin of the subject 602 to provide detectable
stimulation. In other aspects, the electrodes may be embedded or
partially embedded subcutaneously. In other aspects, galvanic skin
response, electrical, electrostatic, or electromagnetic techniques
may be employed to stimulate nerves or muscles to enable
communication between the subject 602 and the body associated
device 604.
[0127] Other aspects of tactile communication techniques include
thermal stimulation techniques. For example, thermoelectric
circuits may be employed on the body associated device 604 to
generated sensations of hot and cold in varying degrees such that
the subject 602 can develop a unique vocabulary based on thermally
generated communications. A simple technique for generating thermal
sensations includes driving a current through a resistor. More
complex techniques exploit the thermoelectric effect where
temperature differences are converted directly to electric voltage
and vice versa. A thermoelectric device creates a voltage when
there is a different temperature on each side. Conversely when a
voltage is applied to it, it creates a temperature difference
(known as the Peltier effect). At atomic scale (specifically,
charge carriers), an applied temperature gradient causes charged
carriers in the material, whether they are electrons or electron
holes, to diffuse from the hot side to the cold side, similar to a
classical gas that expands when heated; hence, the thermally
induced current. The thermoelectric effect can be used to generate
electricity, to measure temperature, to cool objects, or to heat
them. Because the direction of heating and cooling is determined by
the polarity of the applied voltage, thermoelectric devices make
very convenient temperature controllers and thus can be used for
communications between the subject 602 and the body associated
device 604. Traditionally, the term thermoelectric effect or
thermoelectricity encompasses three separately identified effects,
the Seebeck effect, the Peltier effect, and the Thomson effect, any
one of which may be employed to implement various aspects of
tactile communication techniques.
[0128] In other aspects, tactile communication techniques include
haptic sensors such as Electroactive Polymer Artificial Muscles
(EPAM.TM.) based on dielectric elastomers. Such sensors have the
bandwidth and the energy density required to make haptic sensors
that are responsive and compact. Such EPAM.TM. based dielectric
elastomers may be configured into thin, high-fidelity haptic sensor
modules to provide a brief tactile "click" that corresponds to a
key press or tap.
[0129] In one aspect, the feedback module 718 may employ olfactory
and taste communication techniques to enable communication between
the subject 602 (FIG. 30) and the body associated device 604. A
fluidic reservoir filled with an aromatic fluid may be used as a
source for generating smells and tastes. In one aspect, an
electrical current generated by the feedback module 718 may be
driven through the fluidic reservoir to release the aromatic fluid.
The sense of smell or taste may increase proportionately with the
electrical current through the fluidic reservoir. Other techniques
include solid state devices that outgas when an electrical current
is passed therethrough and substrates with aromatic material
embedded in wax that release aromas when an electrical current is
passed therethrough. Such techniques may be configured for single
use or multiuse. Although these techniques are suitable for
communicating information from the body associated device 604 to
the subject 602, the subject 602 may use any other techniques
described herein to communicate information to the body associated
device 604 such as tapping an external housing of the body
associated device 604.
[0130] The body associated device 604 may incorporate various form
factors and materials. In one example, the body associated device
604 may be in the form of a patch similar in design, shape, size,
and material to an adhesive bandage, i.e., may be
removably-attachable to the subject 602 (FIG. 30). Specific
dynamics of design, shape, design, and material may vary according
to use, environment, placement. For example, the design may
incorporate various constructs and patterns. The constructs, for
example, may include one or more layers, e.g., a substrate having
an adhesive layer. The patterns may include various aesthetic
features, e.g., various patterns, various colors, decals, imprints,
etc., and non-aesthetic features, e.g., breathable materials,
non-allergenic materials. The shape may vary, e.g., oval, circular,
triangular, kidney-shaped, rectangular, square. The size may vary,
e.g., approximately 75 mm by 120 mm, approximately 50 mm by 80 mm,
approximately 25 mm by 40 mm, and with a thickness ranging from
approximately 2 mm to approximately 20 mm, or other sizes, as
desired. The material may incorporate any material or combinations
of materials capable of carrying out the functionality of the body
associated device 604 as herein described. Further, in various
aspects, considerations may be given to position, energy
conservation schemes, carrier identification, decoding and error
correcting.
[0131] The processing unit 706 communicate with the sensors 716
and/or other devices. In various aspects, for example, the
processing unit 706 generates electronic communication with the
sensors 716. In one example, the processing unit 706 includes
electronic integrated circuits (not shown). In various aspects, a
housing may include various features, e.g., watertight,
hermetically sealed. The circuit board having electronic circuits
may electronically communicate with the sensors 716. The power unit
702 may, for example, be a rechargeable power source such as a
rechargeable battery. The power unit in another aspect may be a
passive device that receives power from an external source, e.g.,
passive RFID.
[0132] In various aspects, different energy conservation schemes
may be considered. Such schemes include a periodic wake-up, e.g.,
sensors and/or other components wake-up periodically such that
energy, e.g., power source unit 702, is conserved during non-awake
periods. Such energy conservation schemes may be controlled by the
power management module 710.
[0133] In various aspects, the body associated device 604 may
accomplish one or more of sensing functions using a communication
receiving element, e.g., using electrodes of the body associated
device 604 for receiving communications and sensing applications,
or the body associated device 604 may include one or more distinct
sensing elements that are different from the signal receiving
element. The number of distinct sensing elements that may be
present on (or at least coupled to) the signal receiver may vary,
and may be one or more, two or more, three or more, four or more,
five or more, ten or more.
[0134] In various aspects, the body associated device 604 may
include a pair of electrodes that provide for dual functions of
receiving and sensing information or communications. For example,
the electrodes also may serve additional sensing functions. In
certain aspects, the electrodes may be used to generate an IEGM
(intra cardiac electrogram) at whatever site they are located. From
that data, there are many kinds of processing that can be done,
e.g., to detect various cardiac events, such as tachycardia,
fibrillations, heart rate. Another sensing capability that may be
accomplished with two electrodes of the signal receiver employs
measuring the impedance between the electrodes. The measured
impedance will have some component which is determined by the
trans-thoracic impedance, which relates to respiration. In this
manner, the impedance data can be employed to obtain the
respiratory rate of the subject. The electrodes may also be
employed as sensors of fluid state of subject.
[0135] As mentioned above, one or more additional physiologic
sensors distinct from the electrodes may be included in the body
associated device 604. For example, a temperature sensor, e.g., a
thermistor, may be included therein. If really precise temperature
measurement are desired, there are other techniques like resistive
temperature devices (RTDs), made out of platinum generally, which
can give very precise measurements of temperature. An additional
physiological sensor may include an LED and a photodiode combined
into a pulse-oximeter, which may be employed to measure blood
oxygenation, which also may provide information about pulse
pressure.
[0136] In addition, the body associated device 604 may include a
pressure sensor, e.g., where the body associated device 604 is
implanted next to an artery to get measurements of arterial blood
pressure. For example, one can get the pressure inside the body by
putting a pressure sensitive membrane on the surface of the body
associated device 604. To get a more useful type of pressure, one
usually wants to measure the venous or arterial blood pressure. In
such a case, the membrane may be located in proximity to either an
artery or a vein, so that as the artery pulsed it may exert a
pressure on the pressure sensor. That could be calibrated to give
an absolute pressure reading. Another possibility includes some
sort of outrigger cuff, e.g., which cuffed around the artery. It
could have strain gauges in it to measure pressure deflections,
which are then attached to the receiver, e.g., the body associated
device 604.
[0137] Generally, the body associated device 604 may also include
analyte detection sensors. For example, specific chemical sensors
may be incorporated into the signal receivers to detect the
presence of various agents, e.g., glucose, BNP (B-type Natriuretic,
which is associated with cardiac disease). There are other ways
that one could build an oxygen sensor, including selectively porous
impedance cells, where the oxygen changes the pH of a cell, and
then the conductivity of that is measured. Where the signal
receiver includes an analyte detecting sensing element, this
sensing element can be configured in the signal receiver in a
number of different ways. For example, a sensor that includes a
selectively permeable membrane which is permeable to the agent to
be detected may be provided, where there is an isolated cell behind
it, and the agent passes through the membrane, and changes the
properties, usually electrical properties, of the cell, which are
then measured. For example, there may be a small reservoir on the
side of the signal receiver with a membrane across it, and the
measuring electrical circuitry behind it. Another way of detecting
agents employs sensors known in the art as ChemFET sensors, which
are based on the binding of analyte to the sensor causing a change
in the conductivity. There may be included a material with
electrical properties (or other properties) that are changed when
the material binds to it. Various proteins may be detected that
way.
[0138] In one aspect, the body associated device 604 gathers
physiologic data. The physiologic data includes data associated
physiologic events, parameters, measurements. Such data include,
for example, Galvanic skin response, heart rate, heart rate
variability, respiration rate, body temperature, temperature of
local environment, three-axis measurement of activity and torso
angle, optical, pressure, sound, biochemical/biological, weight,
position, derived electromyography (EMG), and
electroencephalography (EEG). The physiologic data further include
those data set out in the U.S. patent application Ser. Nos.
10/734,490; 10/764,429; 10/764,127; 10/764,125; 11/025,657;
11/324,196; 11/664,340; 11/731,786; 11/718,201; 11/897,942;
11/912,475; 12/063,097; 12/063,095; as well as PCT Application
Serial Nos: PCT/US2007/015547; and PCT/US2008/52845, each of which
is incorporated herein in its entirety by reference.
[0139] FIG. 32 is a block functional diagram of one aspect of an
electronic circuit component of a body associated device 604. The
electronic circuit component can be disposed on the printed circuit
board 128 (FIGS. 13-16) or may be formed on an integrated circuit
component, which is then disposed on the printed circuit board 128
or a combination thereof. In FIG. 32, the body associated device
604 includes an electrode input 810. Electrically coupled to the
electrode input 810 are a transbody conductive communication module
820 and a physiological sensing module 830. In one aspect, the
transbody conductive communication module 820 is implemented as a
first, e.g., high, frequency (HF) signal chain and the
physiological sensing module 830 is implemented as a second, e.g.,
low, frequency (LF) signal chain. Also shown are CMOS temperature
sensing module 840 (for detecting ambient temperature) and a 3-axis
accelerometer 850. The body associated device 604 also includes a
processing engine 860 (for example, a microcontroller and digital
signal processor), a non-volatile memory 870 (for data storage),
and a wireless communication module 880 (to receive data from
and/or transmit data to another device, for example in a data
download/upload action, respectively). In various aspects, the
communication modules 820, 880 may comprise one or more
transmitters/receivers ("transceiver") modules. As used herein, the
term "transceiver" may be used in a very general sense to include a
transmitter, a receiver, or a combination of both, without
limitation.
[0140] The sensors 716 typically contact the subject's 602 (FIG.
30) person, e.g., are removably attached to the torso. In various
aspects, the sensors 716 may be removably or permanently attached
to the body associated device 604. For example, the sensors 716 may
be removably connected to the body associated device 604 by
snapping metal studs. The sensors 716 may comprise, for example,
various devices capable of sensing or receiving the physiologic
data. The types of sensors 716 include, for example, electrodes
such as biocompatible electrodes. The sensors 716 may be
configured, for example, as a pressure sensor, a motion sensor, an
accelerometer, an electromyography (EMG) sensor, an ingestible
event marker, a biopotential sensor, an electrocardiogram sensor, a
temperature sensor, a tactile event marker sensor, and an impedance
sensor.
[0141] The feedback module 718 may be implemented with software,
hardware, circuitry, various devices, and combinations thereof. The
function of the feedback module 718 is to provide communication
with the living subject 602 (FIG. 30) in a discreet, tactful,
circumspect manner as described above. In various aspects the
feedback module 718 may be implemented to communicate with the
subject 602 using techniques that employ visual, audio,
vibratory/tactile, olfactory, and taste.
[0142] FIG. 33 illustrates one aspect of a body associated device
604 configured to be placed on an external topical location of a
subject 602 (FIG. 30), such as a chest area. The body associated
device 604 includes an upper housing plate 910 (such as may be
fabricated from a suitable polymeric material), and includes
indicator devices for example, a manually depressible operation
button 902 in communication with a status identifier LED 903, which
may be used to relay to an observer that the signal receiver is
operating. Manually depressible operation button 902 can be
manually manipulated to transition the signal receiver from a
storage mode to a non-storage mode. Manually depressible operation
button 902 can be manually manipulated to transition the signal
receiver from a storage mode to a non-storage mode. When the signal
receiver is in the storage mode, a micro-controller of the signal
receiver may remain in a low duty cycle active state at all times
to process input from the on/off button, and the digital signal
processor (DSP) of the signal receiver powered off. When the on/off
button is depressed to turn on the signal receiver, the
micro-controller de-bounces the input and powers the DSP into its
idle state. While in storage mode, the device may draw less than 10
.mu.A, including 5 .mu.A of current or less, such as 1 .mu.A or
less and including 0.1 .mu.A or less. This configuration enables
the device to remain at greater than 90% useful battery life if
stored for one month (assuming the presence of a 250 mAH battery).
Such a button may also be employed for other functions. For
example, such a button may be employed to instruct the signal
receiver to obtain certain types of data. In addition or
alternatively, such a button may be employed to manually instruct
the signal receiver to transfer data to another device. The various
functional aspects of the feedback module 718 (FIGS. 31, 32) are
incorporated into the body associated device 604 shown in FIG. 33
as may be dictated by a particular application.
Notwithstanding the claims, the invention is also referred to in
the following clauses: 1. A device attachable to the body,
comprising:
[0143] a housing;
[0144] an adhesive layer configured to be applied to a body of a
living subject; and
[0145] a standoff located between the housing and the adhesive
layer.
2. The device of clause 1, wherein the housing and the adhesive
layer define an airgap therebetween. 3. The device of clause 1 or
2, wherein the standoff is defined by any one of a continuous or
broken ring, square, rectangular, oval, kidney shape and a
predetermined thickness. 4. The device of clause 3, wherein the
standoff defines at least one inner aperture configured to receive
an electrode hydrogel therein. 5. The device of clause 4, further
comprising an electrode hydrogel located in the inner aperture. 6.
The body according to any of the preceding clauses wherein the
standoff is formed of a foam material and/or wherein the standoff
comprises a layer of adhesive formed on one end thereof. 7. The
device according to any of the preceding clauses further comprising
an attachment point between the housing and the adhesive layer,
wherein an attachment area is defined by the shape of the standoff.
8. The device of clause 7, wherein the number of attachment points
between the housing and the adhesive ranges from at least 1-10 or
more. 9. The device according to any of the preceding clauses
further comprising a flexible layer attached to the housing. 10.
The device according to clause 9, wherein the housing and the
flexible layer define an airgap therebetween. 11. The device of any
of the clauses 9 or 10, wherein the flexible layer is made of foam.
12. The device of any of the clauses 9-11 wherein the flexible
layer is interposed between the standoff and the housing. 13. The
device according to any of the preceding clauses wherein the
housing is formed of a flexible material. 14. The device according
to any of the preceding clauses wherein the housing comprises a top
portion and a bottom portion, and wherein the top and bottom
portions define a slot therebetween, which slot enables the bottom
portion to flex and adhere to a contour of the body of the living
subject. 15. The device according to any of the preceding clauses
wherein the housing comprises a curved preformed body form factor
to enhance fitment to the body of the living subject. 16. The
device according to any of the preceding clauses wherein the
housing defines at least one pocket formed therein to receive
electrode hydrogel. 17. The device according to any of the
preceding clauses further comprising at least one tiered pocket
configured to receive electrode hydrogel therein, wherein the
tiered pocket forms an expansion slot. 18. The device according to
any of the preceding clauses further comprising an electronic
module located within the housing. 19. The device of clause 18,
comprising at least one conductive element electrically coupled to
the electronic module. 20. The device of clause 18 or 19 further
comprising a transceiver electrically coupled to the electronic
module. 21. The device according to any of the clauses 18-20
comprising a switch electrically coupled to the electronic module.
22. The device according to any of the clauses 18-21 further
comprising a water ingress indicator electrically coupled to the
electronic module. 23. The device according to any of the clauses
18-22 further comprising an energy source to power an indicator
electrically coupled to the electronic module; wherein the
indicator is located within the housing. 24. The device of clause
23, wherein a portion of the housing is formed of a translucent
material to enable energy emitted by the indicator to be
discernable to the living subject or detectable by electronic
components external to the housing. 25. The device according to any
of the clauses 18-24 wherein a hydrogel is electrically coupled to
the circuit module. 26. The device according to any of the
preceding clauses further comprising a physiological sensing module
operative to sense physiological information from the subject. 27.
A personal communication system, comprising a body associated
device according to any of the preceding clauses designed to be
worn by a living subject, the device further comprising a feedback
portion coupled to the housing and to the electronic module, the
feedback portion configured to communicate information between the
living subject and the body associated device; and an external
local node operative to transmit communications to and/or receive
communications from the body associated device. 28. The personal
communication system of clause 27 wherein the body associated
device comprises a wireless communication module operative to
communicate information from the device to the external local node
and/or receive information from the external local node. 29. The
personal communication system of any of the clauses 27-28 further
comprising a remote node operative to communicate at least one of
transmit communications to and receive communications from the
external local node. 30. Use of a device according to any of the
preceding clauses 1-26 for communicating information, preferably
physiological parameters from a subject wearing the device, and/or
for receiving information. 31. Device according to any of the
preceding clauses 1-26 having the form of a patch.
[0146] It is to be understood that this disclosure is not limited
to particular embodiments or aspects described, as such may vary.
It is also to be understood that the terminology used herein is for
the purpose of describing particular embodiments only, and is not
intended to be limiting, since the scope of the present invention
will be limited only by the appended claims.
[0147] Where a range of values is provided, it is understood that
each intervening value, to the tenth of the unit of the lower limit
unless the context clearly dictates otherwise, between the upper
and lower limit of that range and any other stated or intervening
value in that stated range, is encompassed within the invention.
The upper and lower limits of these smaller ranges may
independently be included in the smaller ranges and are also
encompassed within the invention, subject to any specifically
excluded limit in the stated range. Where the stated range includes
one or both of the limits, ranges excluding either or both of those
included limits are also included in the invention.
[0148] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this invention belongs. Although
any methods and materials similar or equivalent to those described
herein can also be used in the practice or testing of the present
invention, representative illustrative methods and materials are
now described.
[0149] All publications and patents cited in this specification are
herein incorporated by reference as if each individual publication
or patent were specifically and individually indicated to be
incorporated by reference and are incorporated herein by reference
to disclose and describe the methods and/or materials in connection
with which the publications are cited. The citation of any
publication is for its disclosure prior to the filing date and
should not be construed as an admission that the present invention
is not entitled to antedate such publication by virtue of prior
invention. Further, the dates of publication provided may be
different from the actual publication dates which may need to be
independently confirmed.
[0150] It is noted that, as used herein and in the appended claims,
the singular forms "a," "an," and "the" include plural referents
unless the context clearly dictates otherwise. It is further noted
that the claims may be drafted to exclude any optional element. As
such, this statement is intended to serve as antecedent basis for
use of such exclusive terminology as solely, only and the like in
connection with the recitation of claim elements, or use of a
negative limitation.
[0151] As will be apparent to those of skill in the art upon
reading this disclosure, each of the individual embodiments
described and illustrated herein has discreet components and
features which may be readily separated from or combined with the
features of any of the other several embodiments without departing
from the scope or spirit of the present invention. Any recited
method can be carried out in the order of events recited or in any
other order which is logically possible.
[0152] Although the foregoing disclosure has been described in some
detail by way of illustration and example for purposes of clarity
of understanding, it is readily apparent to those of ordinary skill
in the art in light of the teachings of this disclosure that
certain changes and modifications may be made thereto without
departing from the scope of the appended claims.
[0153] Accordingly, it will be appreciated that those skilled in
the art will be able to devise various arrangements which, although
not explicitly described or shown herein, embody the principles of
the invention and are included within its scope. Furthermore, all
examples and conditional language recited herein are principally
intended to aid the reader in understanding the principles of the
invention and the concepts contributed by the inventors to
furthering the art, and are to be construed as being without
limitation to such specifically recited examples and conditions.
Moreover, all statements herein reciting principles, aspects, and
embodiments as well as specific examples thereof, are intended to
encompass both structural and functional equivalents thereof.
Additionally, it is intended that such equivalents include both
currently known equivalents and equivalents developed in the
future, i.e., any elements developed that perform the same
function, regardless of structure. The scope of the present
disclosure, therefore, is not intended to be limited to the
exemplary aspects and embodiments shown and described herein.
Rather, the scope of present disclosure is embodied by the appended
claims.
[0154] It is worthy to note that any reference to "one aspect" or
"an aspect" means that a particular feature, structure, or
characteristic described in connection with the aspect is included
in at least one aspect. Thus, appearances of the phrases "in one
aspect" or "in an aspect" in various places throughout the
specification are not necessarily all referring to the same aspect.
Furthermore, the particular features, structures or characteristics
may be combined in any suitable manner in one or more aspects.
[0155] Some aspects may be described using the expression
"attached," "coupled," and "connected" along with their
derivatives. It should be understood that these terms are not
intended as synonyms for each other. For example, some aspects may
be described using the term "connected" to indicate that two or
more elements are in direct physical or electrical contact with
each other. In another example, some aspects may be described using
the term "coupled" to indicate that two or more elements are in
direct physical or electrical contact. The term "coupled," however,
also may mean that two or more elements are not in direct contact
with each other, but yet still co-operate or interact with each
other. In another example, some aspects may be described using the
term "attached" to indicate that two or more elements are in direct
physical contact. The term "attached," however, also may mean that
two or more elements are not in direct contact with each other, but
yet still co-operate or interact with each other.
[0156] While certain features of the aspects have been illustrated
as described herein, many modifications, substitutions, changes and
equivalents will now occur to those skilled in the art. It is
therefore to be understood that the appended claims are intended to
cover all such modifications and changes as fall within the true
spirit of the aspects.
* * * * *